EXPEDIUM 187701015Recalls & reported problems

Summary

The FDA's MAUDE database contains 17 adverse event reports that list this exact device (DI 10705034138336), received between Nov 21, 2017 and Apr 19, 2018 — classified as 17 injuries.

The most frequently reported specific device problem is “Loose or Intermittent Connection” (17 reports).

Reports come from manufacturers, hospitals and patients and are not verified by the FDA. A report does not prove the device caused the event, and counts can't be used to compare devices or estimate failure rates. How this data works · Data updated Oct 13, 2026.

Most reported problems

Recent adverse event reports

The 17 most recent of 17 reports, in the reporter's own words as published by the FDA.

• InjuryApr 19, 2018Loose or Intermittent Connection; Loose or Intermittent Connection

  ON MARCH 26, 2018, IT WAS REPORTED BY THE HOSPITAL THAT THE SAME EVENT AS THE FOLLOWING THREE COMPLAINTS HAD OCCURRED IN 2017. (B)(4). THIS IS THE 4TH SAME EVENT IN WHICH THE EXPEDIUM SET SCREWS (PART#: UNK) FIXED AT THE CAUDAL END HAD BEEN LOOSENED THUS THE CORRECTIVE FORCE WAS LOST. FOR DETAILS, PLEASE REFER TO THE ABOVE THREE COMPLAINTS. NO FURTHER INFORMATION HAS BEEN PROVIDED BY THE HOSPITAL.

  Patient problems: Spinal Column Injury

  MAUDE report 7444114 ↗
• InjuryJan 9, 2018Loose or Intermittent Connection; Loose or Intermittent Connection

  ACCOUNT NAME: (B)(6) HOSPITAL. ON (B)(6) 2016, SURGERY FOR SCOLIOSIS WAS PERFORMED USING THE EXPEDIUM SYSTEM. THE FIXED AREA WAS T10 ¿ L3. RECENTLY, SURGEON CONFIRMED THROUGH AN X-RAY THAT EXPEDIUM SET SCREWS (PART#: UNK) FIXED AT THE CAUDAL END WERE LOOSENED, THUS ITS CORRECTIVE FORCE WAS LOST. CURRENTLY, RE-OPERATION IS NOT SCHEDULED.

  Patient problems: Spinal Column Injury

  MAUDE report 7174989 ↗
• InjuryJan 9, 2018Loose or Intermittent Connection; Loose or Intermittent Connection

  ACCOUNT NAME: (B)(6) HOSPITAL. ON (B)(6) 2016, SURGERY FOR SCOLIOSIS WAS PERFORMED USING THE EXPEDIUM SYSTEM. THE FIXED AREA WAS T10 ¿ L3. RECENTLY, SURGEON CONFIRMED THROUGH AN X-RAY THAT EXPEDIUM SET SCREWS (PART#: UNK) FIXED AT THE CAUDAL END WERE LOOSENED, THUS ITS CORRECTIVE FORCE WAS LOST. CURRENTLY, RE-OPERATION IS NOT SCHEDULED.

  Patient problems: Spinal Column Injury

  MAUDE report 7174971 ↗
• InjuryJan 9, 2018Loose or Intermittent Connection; Loose or Intermittent Connection

  ACCOUNT NAME: (B)(6) HOSPITAL. ON (B)(6) 2016, SURGERY FOR SCOLIOSIS WAS PERFORMED USING THE EXPEDIUM SYSTEM. THE FIXED AREA WAS T10 ¿ L3. RECENTLY, SURGEON CONFIRMED THROUGH AN X-RAY THAT EXPEDIUM SET SCREWS (PART#: UNK) FIXED AT THE CAUDAL END WERE LOOSENED, THUS ITS CORRECTIVE FORCE WAS LOST. CURRENTLY, RE-OPERATION IS NOT SCHEDULED.

  Patient problems: Spinal Column Injury

  MAUDE report 7174927 ↗
• InjuryJan 9, 2018Loose or Intermittent Connection; Loose or Intermittent Connection

  ACCOUNT NAME: (B)(6) HOSPITAL. ON (B)(6) 2016, SURGERY FOR SCOLIOSIS WAS PERFORMED USING THE EXPEDIUM SYSTEM. THE FIXED AREA WAS T10 ¿ L3. RECENTLY, SURGEON CONFIRMED THROUGH AN X-RAY THAT EXPEDIUM SET SCREWS (PART#: UNK) FIXED AT THE CAUDAL END WERE LOOSENED, THUS ITS CORRECTIVE FORCE WAS LOST. CURRENTLY, RE-OPERATION IS NOT SCHEDULED.

  Patient problems: Spinal Column Injury

  MAUDE report 7174834 ↗
• InjuryJan 9, 2018Loose or Intermittent Connection; Loose or Intermittent Connection

  ACCOUNT NAME: (B)(6) HOSPITAL. ON (B)(6) 2016, SURGERY FOR SCOLIOSIS WAS PERFORMED USING THE EXPEDIUM SYSTEM. THE FIXED AREA WAS T10 ¿ L3. RECENTLY, SURGEON CONFIRMED THROUGH AN X-RAY THAT EXPEDIUM SET SCREWS (PART#: UNK) FIXED AT THE CAUDAL END WERE LOOSENED, THUS ITS CORRECTIVE FORCE WAS LOST. CURRENTLY, RE-OPERATION IS NOT SCHEDULED.

  Patient problems: Spinal Column Injury

  MAUDE report 7174806 ↗
• InjuryDec 14, 2017Loose or Intermittent Connection; Loose or Intermittent Connection

  ACCOUNT NAME: (B)(6). ON (B)(6) 2016, SURGERY FOR SCOLIOSIS WAS PERFORMED USING THE EXPEDIUM SYSTEM. THE FIXED AREA WAS T11 ¿ L4. RECENTLY, SURGEON CONFIRMED THROUGH AN X-RAY THAT EXPEDIUM SET SCREWS (PART#: UNK) FIXED AT THE CAUDAL END CAME OFF, THUS ITS CORRECTIVE FORCE WAS LOST. CURRENTLY, RE-OPERATION IS NOT SCHEDULED.

  Patient problems: Spinal Column Injury

  MAUDE report 7118071 ↗
• InjuryDec 14, 2017Loose or Intermittent Connection; Loose or Intermittent Connection

  ACCOUNT NAME: (B)(6). ON (B)(6) 2016, SURGERY FOR SCOLIOSIS WAS PERFORMED USING THE EXPEDIUM SYSTEM. THE FIXED AREA WAS T11 ¿ L4. RECENTLY, SURGEON CONFIRMED THROUGH AN X-RAY THAT EXPEDIUM SET SCREWS (PART#: UNK) FIXED AT THE CAUDAL END CAME OFF, THUS ITS CORRECTIVE FORCE WAS LOST. CURRENTLY, RE-OPERATION IS NOT SCHEDULED.

  Patient problems: Spinal Column Injury

  MAUDE report 7118015 ↗
• InjuryDec 14, 2017Loose or Intermittent Connection; Loose or Intermittent Connection

  ACCOUNT NAME: (B)(6) HOSPITAL. ON (B)(6) 2016, SURGERY FOR SCOLIOSIS WAS PERFORMED USING THE EXPEDIUM SYSTEM. THE FIXED AREA WAS T11 ¿ L4. RECENTLY, SURGEON CONFIRMED THROUGH AN X-RAY THAT EXPEDIUM SET SCREWS (PART#: UNK) FIXED AT THE CAUDAL END CAME OFF, THUS ITS CORRECTIVE FORCE WAS LOST. PLEASE SEE A PHOTO ATTACHED. CURRENTLY, RE-OPERATION IS NOT SCHEDULED.

  Patient problems: Spinal Column Injury

  MAUDE report 7117949 ↗
• InjuryDec 14, 2017Loose or Intermittent Connection; Loose or Intermittent Connection

  ACCOUNT NAME: (B)(6) HOSPITAL. ON (B)(6) 2016, SURGERY FOR SCOLIOSIS WAS PERFORMED USING THE EXPEDIUM SYSTEM. THE FIXED AREA WAS T11 ¿ L4. RECENTLY, SURGEON CONFIRMED THROUGH AN X-RAY THAT EXPEDIUM SET SCREWS (PART#: UNK) FIXED AT THE CAUDAL END CAME OFF, THUS ITS CORRECTIVE FORCE WAS LOST. CURRENTLY, RE-OPERATION IS NOT SCHEDULED.

  Patient problems: Spinal Column Injury

  MAUDE report 7117786 ↗
• InjuryDec 14, 2017Loose or Intermittent Connection; Loose or Intermittent Connection

  ACCOUNT NAME: (B)(6). ON (B)(6) 2016, SURGERY FOR SCOLIOSIS WAS PERFORMED USING THE EXPEDIUM SYSTEM. THE FIXED AREA WAS T11 ¿ L4. RECENTLY, SURGEON CONFIRMED THROUGH AN X-RAY THAT EXPEDIUM SET SCREWS (PART#: UNK) FIXED AT THE CAUDAL END CAME OFF, THUS ITS CORRECTIVE FORCE WAS LOST. CURRENTLY, RE-OPERATION IS NOT SCHEDULED.

  Patient problems: Spinal Column Injury

  MAUDE report 7117690 ↗
• InjuryNov 21, 2017Loose or Intermittent Connection; Loose or Intermittent Connection

  ON (B)(6) 2016, SURGERY FOR SCOLIOSIS WAS PERFORMED USING THE EXPEDIUM SYSTEM. THE FIXED AREA WAS T11 ¿ L4. RECENTLY, SURGEON CONFIRMED THROUGH AN X-RAY THAT SET SCREWS (PART#: UNK) FIXED AT CAUDAL END WERE LOOSENED AND THAT RODS HAD MOVED IN UPPER POSITION, RESULTING IN LOSS OF THE CORRECTIVE FORCE. THE SURGEON DECIDED TO CONDUCT RE-OPERATION NEXT WEEK BECAUSE SUCH LOOSENED SET SCREWS MIGHT CONTACT THE HEART OF THE PATIENT. HE WILL USE NON-J&J REPLACEMENTS AT THE RE-OPERATION SCHEDULED NEXT WEEK.

  Patient problems: Failure of Implant; Injury

  MAUDE report 7050168 ↗
• InjuryNov 21, 2017Loose or Intermittent Connection; Loose or Intermittent Connection

  ON (B)(6) 2016, SURGERY FOR SCOLIOSIS WAS PERFORMED USING THE EXPEDIUM SYSTEM. THE FIXED AREA WAS T11 ¿ L4. RECENTLY, SURGEON CONFIRMED THROUGH AN X-RAY THAT SET SCREWS (PART#: UNK) FIXED AT CAUDAL END WERE LOOSENED AND THAT RODS HAD MOVED IN UPPER POSITION, RESULTING IN LOSS OF THE CORRECTIVE FORCE. THE SURGEON DECIDED TO CONDUCT RE-OPERATION NEXT WEEK BECAUSE SUCH LOOSENED SET SCREWS MIGHT CONTACT THE HEART OF THE PATIENT. HE WILL USE NON-J&J REPLACEMENTS AT THE RE-OPERATION SCHEDULED NEXT WEEK.

  Patient problems: Failure of Implant; Injury

  MAUDE report 7050167 ↗
• InjuryNov 21, 2017Loose or Intermittent Connection; Loose or Intermittent Connection

  ON (B)(6) 2016, SURGERY FOR SCOLIOSIS WAS PERFORMED USING THE EXPEDIUM SYSTEM. THE FIXED AREA WAS T11 ¿ L4. RECENTLY, SURGEON CONFIRMED THROUGH AN X-RAY THAT SET SCREWS (PART#: UNK) FIXED AT CAUDAL END WERE LOOSENED AND THAT RODS HAD MOVED IN UPPER POSITION, RESULTING IN LOSS OF THE CORRECTIVE FORCE. THE SURGEON DECIDED TO CONDUCT RE-OPERATION NEXT WEEK BECAUSE SUCH LOOSENED SET SCREWS MIGHT CONTACT THE HEART OF THE PATIENT. HE WILL USE NON-J&J REPLACEMENTS AT THE RE-OPERATION SCHEDULED NEXT WEEK.

  Patient problems: Failure of Implant; Injury

  MAUDE report 7050102 ↗
• InjuryNov 21, 2017Loose or Intermittent Connection; Loose or Intermittent Connection

  ON (B)(6) 2016, SURGERY FOR SCOLIOSIS WAS PERFORMED USING THE EXPEDIUM SYSTEM. THE FIXED AREA WAS T11 ¿ L4. RECENTLY, SURGEON CONFIRMED THROUGH AN X-RAY THAT SET SCREWS (PART#: UNK) FIXED AT CAUDAL END WERE LOOSENED AND THAT RODS HAD MOVED IN UPPER POSITION, RESULTING IN LOSS OF THE CORRECTIVE FORCE. THE SURGEON DECIDED TO CONDUCT RE-OPERATION NEXT WEEK BECAUSE SUCH LOOSENED SET SCREWS MIGHT CONTACT THE HEART OF THE PATIENT. HE WILL USE NON-J&J REPLACEMENTS AT THE RE-OPERATION SCHEDULED NEXT WEEK.

  Patient problems: Failure of Implant; Injury

  MAUDE report 7050002 ↗
• InjuryNov 21, 2017Loose or Intermittent Connection; Loose or Intermittent Connection

  ON (B)(6) 2016, SURGERY FOR SCOLIOSIS WAS PERFORMED USING THE EXPEDIUM SYSTEM. THE FIXED AREA WAS T11 ¿ L4. RECENTLY, SURGEON CONFIRMED THROUGH AN X-RAY THAT SET SCREWS (PART#: UNK) FIXED AT CAUDAL END WERE LOOSENED AND THAT RODS HAD MOVED IN UPPER POSITION, RESULTING IN LOSS OF THE CORRECTIVE FORCE. THE SURGEON DECIDED TO CONDUCT RE-OPERATION NEXT WEEK BECAUSE SUCH LOOSENED SET SCREWS MIGHT CONTACT THE HEART OF THE PATIENT. HE WILL USE NON-J&J REPLACEMENTS AT THE RE-OPERATION SCHEDULED NEXT WEEK.

  Patient problems: Failure of Implant; Injury

  MAUDE report 7049714 ↗
• InjuryNov 21, 2017Loose or Intermittent Connection; Loose or Intermittent Connection

  ON (B)(6) 2016, SURGERY FOR SCOLIOSIS WAS PERFORMED USING THE EXPEDIUM SYSTEM. THE FIXED AREA WAS T11 ¿ L4. RECENTLY, SURGEON CONFIRMED THROUGH AN X-RAY THAT SET SCREWS (PART#: UNK) FIXED AT CAUDAL END WERE LOOSENED AND THAT RODS HAD MOVED IN UPPER POSITION, RESULTING IN LOSS OF THE CORRECTIVE FORCE. THE SURGEON DECIDED TO CONDUCT RE-OPERATION NEXT WEEK BECAUSE SUCH LOOSENED SET SCREWS MIGHT CONTACT THE HEART OF THE PATIENT. HE WILL USE NON-J&J REPLACEMENTS AT THE RE-OPERATION SCHEDULED NEXT WEEK.

  Patient problems: Failure of Implant; Injury

  MAUDE report 7049636 ↗